It is well known to deliver aerosolized medicaments to a patient via various devices, including nebulizers and aerosol dispensing devices, such as pressurized Metered Dose Inhalers (PMDI's), in order to treat various conditions and diseases, including but not limited to various respiratory conditions and diseases such as asthma. For example, premature babies, termed neonate or pre-term babies, are often born with underdeveloped lungs and may be prone to lung infections such as pneumonia. Preterm babies also may suffer from respiratory distress syndrome (RDS), wherein their lungs lack a surfactant necessary to prevent the air sacks from collapsing, leading to breathing difficulties.
Along with delivery of aerosolized medication directly to targeted areas within the lungs, it may also be desirable to deliver certain gases, such as oxygen, or vapor of a substance, such an aromatic substance, to a patient having difficulty breathing. In some configurations, the device is configured with a patient interface mouthpiece, which is inserted into the mouth of a user such that the aerosolized medicament can be inhaled into the lungs of the user. In other embodiments, the patient interface is configured as a mask, which typically is fitted around the nose and mouth of the user so as to maximize and ensure inhalation of the aerosolized medicament into the lungs of the user.
These types of patient interfaces may not be ideally suited for certain patients, however, such as infants. Infants may tend to reject having a mask positioned over their face and thereby covering their nose and mouth. The infant may become cranky, irritable and prone to crying, which reduces the likelihood of delivering a proper amount of the desired substance, such as a medicament.
In addition, infants up to the age of 18 months are primarily nose breathers. With such patients, the mouth rarely has a role in inhalation except in situations where there is a complete occlusion of the nasal passageways. Moreover, infants are not capable of understanding and/or following instructions to inhale only through their mouth, e.g., if a mouthpiece is introduced therein, and the likelihood of delivering the proper amount of medicament is greatly reduced with such a device. As such, a need remains for an improved device capable of delivering an aerosolized medicament, gas, or other desired substance to the nasal passageways of a patient, particularly infants, without causing anxiety and distress to the patient.
Neonates also have very delicate skin, which may be susceptible to irritation, abrasion and other potential damage when engaged by a non-pliable mask, made for example from hard plastic or with relative thick walls. Conversely, masks made entirely of silicone or soft polymer may be susceptible to buckling or collapse if made with thin walls, which may have a negative impact on aerosol delivery. As such, a need remains for an improved mask for use with users, such as neonates, having sensitive skin, even when covering either or both of the mouth or nose of the user.